Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation

NCT ID: NCT06953752

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-06
• Study Completion Date: 2026-12-30

Brief Summary

I. Background Atrial fibrillation, a common type of arrhythmia, is often treated with radiofrequency catheter ablation, a minimally invasive procedure that helps restore a normal heart rhythm. While this surgery is typically performed under "light sedation" (where patients remain semi-awake) and allows for quick recovery, many patients still experience significant anxiety during the procedure due to pain, unfamiliar surroundings, or concerns about surgical risks. Research shows that anxiety not only makes people more sensitive to pain but can also trigger physical tension, irregular breathing, and even affect the precision of the surgeon's movements-potentially prolonging the procedure or increasing the risk of complications.

Currently, hospitals primarily rely on sedatives and painkillers to ease patient discomfort. However, these medications may cause side effects like low blood pressure or slowed breathing, which can be particularly dangerous for older patients with heart conditions. As a safer alternative, non-drug approaches like music therapy are gaining attention. Studies suggest that listening to music can reduce anxiety and pain in other medical settings (such as during biopsies or pre-surgery preparation), likely because it helps the body relax, reduces stress hormones, or distracts the mind. Yet, there's limited evidence on whether music can provide similar benefits during atrial fibrillation catheter ablation, especially in helping patients maintain steady breathing.

To address this gap, the present study aims to explore how music interventions affect anxiety, pain, and breathing stability in patients undergoing atrial fibrillation catheter ablation. Investigators hope this research will offer practical solutions to improve patient comfort, reduce reliance on medications, and enhance surgical safety, while also providing scientific support for expanding non-drug therapies in cardiac procedures.

II. Study Purpose To evaluate whether music during atrial fibrillation catheter ablation helps reduce patients' anxiety and pain, stabilize breathing, and improve satisfaction for both patients and doctors while making the procedure more efficient.

III. Study Design Prospective randomized controlled trial

IV. Study Plan

1. Participants

Inclusion Criteria:

• First-time atrial fibrillation ablation patients (aged 18-80) following clinical guidelines.
• Willing to participate and sign consent.

Exclusion Criteria:

• Mental health issues (e.g., anxiety requiring medication, sleep disorders).
• Hearing loss, communication difficulties, or need for general anesthesia.
• Prior heart surgeries or catheter ablation, complex heart anatomy, or recent pain/sedation medication use.

Grouping: Patients split evenly into "music group" or "control group," based on atrial fibrillation type (persistent or paroxysmal).

2. Sample Size 60 patients/group (120 total) will be chosen.

3. Blinding

• Patients and doctors know the group assignment (music or no music).
• Researchers assessing pain/anxiety and statisticians are blinded.

4. Data Collected

• Basic info (age, weight, education).
• Health history (smoking, heart conditions, medications).
• Atrial fibrillation details (type, duration).
• Test results (e.g., heart size, kidney function).

5. Pain/Sedation Protocol

• Light sedation with fentanyl (adjusted as needed).
• Extra midazolam given if heart rhythm needs electric correction.

6. Ablation Procedure

• For Paroxysmal atrial fibrillation: Isolate lung veins.
• For Persistent atrial fibrillation: Extra ablation lines on heart walls.
• Power and pressure settings vary by heart area to balance safety and effectiveness.

7. Music Intervention

• Music Group: Patients pick preferred music (classical, pop, etc.) played at 50-60 dB during procedure.
• Control Group:*No music.

8. Outcomes Measured

Main Outcomes:

• Pain: Rated by patients post-surgery using a face-based scale.
• Anxiety: Measured before and after surgery with a standard questionnaire.

Secondary Outcomes:

• Breathing Stability: Breathing rate, pauses, and patterns.
• Procedure Efficiency: Surgery duration, X-ray time, success rate.
• Complications: Bleeding, heart injury, stroke risk.
• Drug Use: Amount of painkillers needed.
• Satisfaction: Ratings from patients and doctors (1-5 scale).
• Doctor Fatigue: Self-reported by surgeons.

Conditions

Atrial Fibrillation (AF); Catheter Ablation; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Music intervention

1. Intraoperative Analgesia and Sedation Protocol:

The procedure is performed under conscious sedation using fentanyl (1 ug/kg loading dose post-transseptal puncture, then 1-2 ug/kg/h maintenance infusion titrated in 0.25 ug/kg/h increments). Midazolam 3-5 mg is administered for cardioversion with flumazenil reversal.

2. Ablation Protocol:

Ablation is performed using EnSite/CARTO systems. Paroxysmal AF patients receive bilateral pulmonary vein isolation ± trigger ablation; persistent AF patients receive additional posterior wall box ablation. Endpoints include bidirectional PVI (20-min observation) and roof line block. Posterior wall ablation is optional due to esophageal risk.

3. Music Intervention:

Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure.

Group Type: EXPERIMENTAL

Music intervention

Intervention Type: OTHER

Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure.

Control

1. Intraoperative Analgesia and Sedation Protocol:

The procedure is performed under conscious sedation using fentanyl (1 ug/kg loading dose post-transseptal puncture, then 1-2 ug/kg/h maintenance infusion titrated in 0.25 ug/kg/h increments). Midazolam 3-5 mg is administered for cardioversion with flumazenil reversal.

2. Ablation Protocol:

Ablation is performed using EnSite/CARTO systems. Paroxysmal AF patients receive bilateral pulmonary vein isolation ± trigger ablation; persistent AF patients receive additional posterior wall box ablation. Endpoints include bidirectional PVI (20-min observation) and roof line block. Posterior wall ablation is optional due to esophageal risk.

3. Music Intervention:

Controls receive no music.

Group Type: OTHER

Control

Intervention Type: OTHER

Controls receive no music.

Interventions

Music intervention

Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure.

Intervention Type: OTHER

Control

Controls receive no music.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing first-time catheter radiofrequency ablation for atrial fibrillation at our center according to guideline recommendations;

2. Aged 18-80 years;

3. Willing to participate in the study and providing signed informed consent.

Exclusion Criteria

1. Active psychiatric conditions necessitating pharmacotherapy;

2. Auditory/cognitive barriers to protocol compliance;

3. General anesthesia candidates;

4. Hybrid AF procedures (e.g., concomitant LAA occlusion);

5. Previous cardiac interventions;

6. Complex anatomies per preprocedural imaging (e.g., persistent left superior vena cava, cor triatriatum);

7. Recent (≤30 days) sedative/analgesic exposure."

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaoxing People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Buyun Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Buyun Xu

Role: primary

xbyzju@zju.edu.cn

15088681639

Other Identifiers

IEC-K-AF-016-1.3

Identifier Type: -

Identifier Source: org_study_id